[Federal Register Volume 75, Number 123 (Monday, June 28, 2010)] [Notices] [Pages 36786-37185] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2010-15257] [[Page 36785]] ----------------------------------------------------------------------- Part II Book 2 of 2 Books Pages 36785-37286 Department of Health and Human Services ----------------------------------------------------------------------- Centers for Medicare & Medicaid Services ----------------------------------------------------------------------- Medicare and Medicaid Programs; Quarterly Listing of Program; Notice Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices [[Page 36786]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-9059-N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--January Through March 2010 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2010, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare- approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomogrogphy for dementia, and a list of Medicare-approved bariatric surgery facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame. FOR FURTHER INFORMATION CONTACT: It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning these items. Copies are not available through the contact persons. (See Section III of this notice for how to obtain listed material.) Questions concerning CMS manual instructions in Addendum III may be addressed to Ismael Torres, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-1864. Questions concerning regulation documents published in the Federal Register in Addendum IV may be addressed to Kathleen Smith, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C4-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-0626. Questions concerning Medicare NCDs in Addendum V may be addressed to Patricia Brocato-Simons, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-0261. Questions concerning FDA-approved Category B IDE numbers listed in Addendum VI may be addressed to John Manlove, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-13- 04, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6877. Questions concerning approval numbers for collections of information in Addendum VII may be addressed to Melissa Musotto, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-14- 03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6962. Questions concerning Medicare-approved carotid stent facilities in Addendum VIII may be addressed to Sarah J. McClain, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09- 06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-2994. Questions concerning Medicare's recognition of the American College of Cardiology-National Cardiovascular Data Registry sites in Addendum IX may be addressed to JoAnna Baldwin, MS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-7205. Questions concerning Medicare's active coverage-related guidance documents in Addendum X may be addressed to Beverly Lofton, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-7136. Questions concerning one-time notices regarding national coverage provisions in Addendum XI may be addressed to Beverly Lofton, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-7136. Questions concerning National Oncologic Positron Emission Tomography Registry sites in Addendum XII may be addressed to Stuart Caplan, RN, MAS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-8564. Questions concerning Medicare-approved ventricular assist device (destination therapy) facilities in Addendum XIII may be addressed to JoAnna Baldwin, MS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-7205. Questions concerning Medicare-approved lung volume reduction surgery facilities listed in Addendum XIV may be addressed to JoAnna Baldwin, MS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-7205. Questions concerning Medicare-approved bariatric surgery facilities listed in Addendum XV may be addressed to Kate Tillman, RN, MA, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-9252. Questions concerning fluorodeoxyglucose positron emission [[Page 36787]] tomography for dementia trials listed in Addendum XVI may be addressed to Stuart Caplan, RN, MAS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-8564. Questions concerning all other information may be addressed to Kathleen Smith, Office of Strategic Operations and Regulatory Affairs, Regulations Development Group, Centers for Medicare & Medicaid Services, C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-0626. SUPPLEMENTARY INFORMATION: I. Program Issuances The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs. These programs pay for health care and related services for 39 million Medicare beneficiaries and 35 million Medicaid recipients. Administration of the two programs involves (1) furnishing information to Medicare beneficiaries and Medicaid recipients, health care providers, and the public and (2) maintaining effective communications with regional offices, State governments, State Medicaid agencies, State survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, and others. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act). We also issue various manuals, memoranda, and statements necessary to administer the programs efficiently. Section 1871(c)(1) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register. We published our first notice June 9, 1988 (53 FR 21730). Although we are not mandated to do so by statute, for the sake of completeness of the listing of operational and policy statements, and to foster more open and transparent collaboration, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the respective 3-month time frame. II. How To Use the Addenda This notice is organized so that a reader may review the subjects of manual issuances, memoranda, substantive and interpretive regulations, NCDs, and FDA-approved IDEs published during the subject quarter to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals may wish to review Table I of our first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) published in 1988, and the notice published March 31, 1993 (58 FR 16837). Those desiring information on the Medicare NCD Manual (NCDM, formerly the Medicare Coverage Issues Manual (CIM)) may wish to review the August 21, 1989, publication (54 FR 34555). Those interested in the revised process used in making NCDs under the Medicare program may review the September 26, 2003, publication (68 FR 55634). To aid the reader, we have organized and divided this current listing into 11 addenda:Addendum I lists the publication dates of the most recent quarterly listings of program issuances. Addendum II identifies previous Federal Register documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda. Addendum III lists a unique CMS transmittal number for each instruction in our manuals or Program Memoranda and its subject matter. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manuals. Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the Federal Register during the quarter covered by this notice. For each item, we list the-- [cir] Date published; [cir] Federal Register citation; [cir] Parts of the Code of Federal Regulations (CFR) that have changed (if applicable); [cir] Agency file code number; and [cir] Title of the regulation. Addendum V includes completed NCDs, or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCDM in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. Addendum VI includes listings of the FDA-approved IDE categorizations, using the IDE numbers the FDA assigns. The listings are organized according to the categories to which the device numbers are assigned (that is, Category A or Category B), and identified by the IDE number. Addendum VII includes listings of all approval numbers from the Office of Management and Budget (OMB) for collections of information in CMS regulations in title 42; title 45, subchapter C; and title 20 of the CFR. Addendum VIII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients. Addendum IX includes a list of the American College of Cardiology's National Cardiovascular Data registry sites. We cover implantable cardioverter defibrillators (ICDs) for certain indications, as long as information about the procedures is reported to a central registry. Addendum X includes a list of active CMS guidance documents. As required by section 731 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108- 173, enacted on December 8, 2003), we will begin listing the current versions of our guidance documents in each quarterly listings notice. Addendum XI includes a list of special one-time notices regarding national coverage provisions. We are publishing a list of issues that require public notification, such as a particular clinical trial or research study that qualifies for Medicare coverage. Addendum XII includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission tomography (PET) scans for particular oncologic indications when they are performed in a facility that participates in the NOPR. Addendum XIII includes a listing of Medicare-approved facitilites that receive coverage for ventricular assist devices used as destination therapy. All facilities were required to meet our standards in order to receive coverage for ventricular assist devices implanted as destination therapy. Addendum XIV includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial are also eligible to receive coverage. Addendum XV includes a listing of Medicare-approved facilities that meet minimum standards for facilities modeled in part on professional society statements on competency. All facilities [[Page 36788]] must meet our standards in order to receive coverage for bariatric surgery procedures. Addendum XVI includes a listing of Medicare-approved clinical trials for fluorodeoxyglucose positron emission tomography (FDG-PET) for dementia and neurodegenerative diseases. III. How To Obtain Listed Material A. Manuals Those wishing to subscribe to program manuals should contact either the Government Printing Office (GPO) or the National Technical Information Service (NTIS) at the following addresses: Superintendent of Documents, Government Printing Office, ATTN: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 512-1800, Fax number (202) 512-2250 (for credit card orders); or National Technical Information Service, Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630. In addition, individual manual transmittals and Program Memoranda listed in this notice can be purchased from NTIS. Interested parties should identify the transmittal(s) they want. GPO or NTIS can give complete details on how to obtain the publications they sell. Additionally, most manuals are available at the following Internet address: http://cms.hhs.gov/manuals/default.asp. B. Regulations and Notices Regulations and notices are published in the daily Federal Register. Interested individuals may purchase individual copies or subscribe to the Federal Register by contacting the GPO at the address given above. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number. The Federal Register is also available on 24x microfiche and as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) forward. Free public access is available on a Wide Area Information Server (WAIS) through the Internet and via asynchronous dial-in. Internet users can access the database by using the World Wide Web; the Superintendent of Documents home page address is http://www.gpoaccess.gov/fr/index.html, by using local WAIS client software, or by telnet to swais.gpoaccess.gov, then log in as guest (no password required). Dial-in users should use communications software and modem to call (202) 512-1661; type swais, then log in as guest (no password required). C. Rulings We publish rulings on an infrequent basis. CMS Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. Interested individuals can obtain copies from the nearest CMS Regional Office or review them at the nearest regional depository library. We have, on occasion, published rulings in the Federal Register. Rulings, beginning with those released in 1995, are available online, through the CMS Home Page. The Internet address is http://cms.hhs.gov/rulings. D. CMS' Compact Disk-Read Only Memory (CD-ROM) Our laws, regulations, and manuals are also available on CD-ROM and may be purchased from GPO or NTIS on a subscription or single copy basis. The Superintendent of Documents list ID is HCLRM, and the stock number is 717-139-00000-3. The following material is on the CD-ROM disk: Titles XI, XVIII, and XIX of the Act. CMS-related regulations. CMS manuals and monthly revisions. CMS program memoranda. The titles of the Compilation of the Social Security Laws are current as of January 1, 2005. (Updated titles of the Social Security Laws are available on the Internet at http://www.ssa.gov/OP_Home/ssact/comp-toc.htm.) The remaining portions of CD-ROM are updated on a monthly basis. Because of complaints about the unreadability of the Appendices (Interpretive Guidelines) in the State Operations Manual (SOM), as of March 1995, we deleted these appendices from CD-ROM. We intend to re- visit this issue in the near future and, with the aid of newer technology, we may again be able to include the appendices on CD-ROM. Any cost report forms incorporated in the manuals are included on the CD-ROM disk as LOTUS files. LOTUS software is needed to view the reports once the files have been copied to a personal computer disk. IV. How To Review Listed Material Transmittals or Program Memoranda can be reviewed at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most Federal Government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. For each CMS publication listed in Addendum III, CMS publication and transmittal numbers are shown. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the Medicare Benefit Policy publication titled ``Outpatient Intravenous Insulin Treatment (Therapy),'' use CMS-Pub. 100-03, Transmittal No. 112. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare--Hospital Insurance, Program No. 93.774, Medicare-- Supplementary Medical Insurance Program, and Program No. 93.714, Medical Assistance Program) Dated: June 15, 2010. Jacquelyn Y. White, Director, Office of Strategic Operations and Regulatory Affairs. Addendum I This addendum lists the publication dates of the most recent quarterly listings of program issuances. April 1, 2008 (73 FR 17422) June 27, 2008 (73 FR 36596) September 26, 2008 (73 FR 55902) December 30, 2008 (73 FR 79982) March 27, 2009 (74 FR 13516) June 26, 2009 (74 FR 30689) September 25, 2009 (74 FR 49076) December 18, 2009 (74 FR 67310) March 26, 2010 (75 FR 14906) Addendum II--Description of Manuals, Memoranda, and CMS Rulings An extensive descriptive listing of Medicare manuals and memoranda was published on June 9, 1988, at 53 FR 21730 and supplemented on September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 50577. Also, a complete description of the former CIM [[Page 36789]] (now the NCDM) was published on August 21, 1989, at 54 FR 34555. A brief description of the various Medicaid manuals and memoranda that we maintain was published on October 16, 1992, at 57 FR 47468. ADDENDUM III Medicare and Medicaid Manual Instructions January Through March 2010 [[Page 36790]] [GRAPHIC] [TIFF OMITTED] TN28JN10.001 [[Page 36791]] [GRAPHIC] [TIFF OMITTED] TN28JN10.002 [[Page 36792]] [GRAPHIC] [TIFF OMITTED] TN28JN10.003 [[Page 36793]] [GRAPHIC] [TIFF OMITTED] TN28JN10.004 [[Page 36794]] [GRAPHIC] [TIFF OMITTED] TN28JN10.005 [[Page 36795]] [GRAPHIC] [TIFF OMITTED] TN28JN10.006 [[Page 36796]] [GRAPHIC] [TIFF OMITTED] TN28JN10.007 [[Page 36797]] [GRAPHIC] [TIFF OMITTED] TN28JN10.008 [[Page 36798]] [GRAPHIC] [TIFF OMITTED] TN28JN10.009 [[Page 36799]] [GRAPHIC] [TIFF OMITTED] TN28JN10.010 [[Page 36800]] [GRAPHIC] [TIFF OMITTED] TN28JN10.011 [[Page 36801]] [GRAPHIC] [TIFF OMITTED] TN28JN10.012 [[Page 36802]] [GRAPHIC] [TIFF OMITTED] TN28JN10.013 [[Page 36803]] Addendum IV--Regulation Documents Published in the Federal Register January Through March 2010 ---------------------------------------------------------------------------------------------------------------- FR Vol. 75 42 CFR Parts Publication date Page No. affected File code Title of regulation ---------------------------------------------------------------------------------------------------------------- January 13, 2010................ 1844 412, 413, 422, and CMS-0033-P......... Medicare and Medicaid 495. Programs; Electronic Health Record Incentive Program. January 22, 2010................ 3742 ................... CMS-7017-N2........ Medicare Program; Meeting of the Advisory Panel on Medicare Education; Cancellation of the February 3, 2010 Meeting and Announcement of the March 31, 2010 Meeting. 3743 ................... CMS-1566-N......... Medicare Program; Meeting of the Practicing Physicians Advisory Council, March 8, 2010. January 26, 2010................ 4088 ................... CMS-6023-N2........ Medicare Program; Approval of Independent Accrediting Organizations To Participate in the Advanced Diagnostic Imaging Supplier Accreditation Program. 4095 ................... CMS-3222-N......... Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee, March 24, 2010. February 2, 2010................ 5410 45 CFR 146......... CMS-4140-IFC....... Interim Final Rules Under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008. February 3, 2010................ 5599 ................... CMS-1341-NC........ Medicare and Medicaid Programs; Announcement of Applications From Hospitals Requesting Waiver for Organ Procurement Service Area. February 24, 2010............... 8374 ................... CMS-1566-CN........ Medicare Program; Meeting of the Practicing Physicians Advisory Council, March 8, 2010, Correction. February 26, 2010............... 8971 ................... CMS-1514-N......... Medicare Program; Public Meetings in Calendar Year 2010 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations. February 26, 2010............... 8980 ................... CMS-3223-N......... Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee--April 22, 2010. February 26, 2010............... 8982 ................... CMS-3224-N......... Medicare Program; Request for Nominations for Members of the Medicare Evidence Development & Coverage Advisory Committee. March 26, 2010.................. 14606 ................... CMS-1570-N......... Medicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups. March 26, 2010.................. 14906 ................... CMS-9057-N......... Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--October Through December 2009. March 31, 2010.................. 16149 ................... CMS-2312-N......... Medicaid and CHIP Programs; Meeting of the CHIP Working Group--April 26, 2010. ---------------------------------------------------------------------------------------------------------------- Addendum V--National Coverage Determinations [January Through March 2010] A national coverage determination (NCD) is a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act, but does not include a determination of what code, if any, is assigned to a particular item or service covered under this title, or determination with respect to the amount of payment made for a particular item or service so covered. We include below all of the NCDs that were issued during the quarter covered by this notice. The entries below include information concerning completed decisions as well as sections on program and decision memoranda, which also announce pending decisions or, in some cases, explain why it was not appropriate to issue an NCD. We identify completed decisions by the section of the NCDM in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. Information on completed decisions as well as pending decisions has also been posted on the CMS Web site at http://cms.hhs.gov/coverage. ---------------------------------------------------------------------------------------------------------------- Title NCDM Section TN No. Issue date Effective date ---------------------------------------------------------------------------------------------------------------- Repeal of Section 20.10, Cardiac 20.10 R116NCD 03/05/2010 02/22/2010 Rehabilitation (CR) Programs............... Percutaneous Transluminal Angioplasty (PTA) 20.70 R115NCD 03/05/2010 12/09/2009 of the Carotid Artery Concurrent with Stenting................................... Outpatient Intravenous Insulin Treatment 40.70 R117NCD 03/09/2010 12/23/2009 (Therapy).................................. Screening for the Human Immunodeficiency 210.70 R118NCD 03/23/2010 12/08/2009 Virus (HIV) Infection...................... [[Page 36804]] Positron Emission Tomography (NaF-18) to 220.60 R119NCD 03/26/2010 02/26/2010 Identify Bone Metastasis of Cancer......... Changes to the Laboratory National Coverage 190.00 R1963CP 04/30/2010 07/01/2010 Determination (NCD) Edit Software for July 2010....................................... ---------------------------------------------------------------------------------------------------------------- Addendum VI--FDA-Approved Category B IDEs [January Through March 2010] Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved IDE. Category A refers to experimental IDEs, and Category B refers to non-experimental IDEs. To obtain more information about the classes or categories, please refer to the Federal Register notice published on April 21, 1997 (62 FR 19328). The following list includes all Category B IDEs approved by FDA during the first quarter, January through March 2010. ------------------------------------------------------------------------ IDE Category ------------------------------------------------------------------------ BB14319..................................... B BB14334..................................... B BB14335..................................... B G080150..................................... B G090029..................................... B G090050..................................... B G090105..................................... B G090188..................................... B G090221..................................... B G090230..................................... B G090251..................................... B G090255..................................... B G090258..................................... B G090259..................................... B G090267..................................... B G090270..................................... B G090272..................................... B G090273..................................... B G090277..................................... B G100008..................................... B G100009..................................... B G100020..................................... B G100024..................................... B G100031..................................... B G100032..................................... B G100035..................................... B G100041..................................... B ------------------------------------------------------------------------ Addendum VII--Approval Numbers for Collections of Information Below we list all approval numbers for collections of information in the referenced sections of CMS regulations in Title 42; Title 45, Subchapter C; and Title 20 of the Code of Federal Regulations, which have been approved by the Office of Management and Budget: [[Page 36805]] [GRAPHIC] [TIFF OMITTED] TN28JN10.014 [[Page 36806]] [GRAPHIC] [TIFF OMITTED] TN28JN10.015 [[Page 36807]] [GRAPHIC] [TIFF OMITTED] TN28JN10.016 [[Page 36808]] [GRAPHIC] [TIFF OMITTED] TN28JN10.017 [[Page 36809]] [GRAPHIC] [TIFF OMITTED] TN28JN10.018 [[Page 36810]] [GRAPHIC] [TIFF OMITTED] TN28JN10.019 [[Page 36811]] Addendum VIII--Medicare-Approved Carotid Stent Facilities [January Through March 2010] On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. ---------------------------------------------------------------------------------------------------------------- Facility Provider No. Effective date State Additional information ---------------------------------------------------------------------------------------------------------------- Palm Springs General Hospital, 100050 01/12/2010 FL .......................... 1475 West 49th Street, Hialeah, FL 33012. Parrish Medical Center, 951 N. 100028 01/12/2010 FL .......................... Washington Avenue, Titusville, FL 32796. New York Presbyterian Hospital, 330101 05/05/2005 NY .......................... 177 Ft. Washington Avenue, New York, NY 10032. Northside Hospital & Tampa Bay 1205880945 02/26/2010 FL .......................... Heart Institute, 6000 49th Street North, St.. Petersburg, FL 33709............. Orange Park Medical Center, 2001 100226 02/26/2010 FL .......................... Kingsley Avenue,. Orange Park, FL 32073............. Saint Thomas Hospital, 4220 440082 02/26/2010 TN .......................... Harding Road, Nashville, TN 37205. Marshall Medical Center North, 15082417 04/02/2010 AL .......................... 8000 Alabama HWT 69, Guntersville, AL 35976. Oklahoma Heart Hospital South LLC, 1841442274 04/02/2010 OK .......................... 5200 E. I-240 Service Road, Oklahoma City, OK 73135-2610. Great River Medical Center, 1221 420680407 04/16/2010 IA .......................... S. Gear Avenue, West Burlington, IA 52655-1681. Liberty Hospital, P.O. Box 1002, 260177 04/16/2010 MO .......................... Liberty, MO 64069-1002. Scripps Memorial Hospital, 050503 04/16/2010 CA .......................... Encinitas, 354 Santa Fe Drive ENC01, Encinitas, CA 92024. University of Maryland Medical 210002 04/16/2010 MD .......................... Center, 22 South Greene Street, Baltimore, MD 21201-1595. ---------------------------------------------------------------------------------------------------------------- Addendum IX American College of Cardiology's National Cardiovascular Data Registry Sites [January Through March 2010] In order to obtain reimbursement, Medicare national coverage policy requires that providers implanting ICDs for primary prevention clinical indications (that is, patients without a history of cardiac arrest or spontaneous arrhythmia) report data on each primary prevention ICD procedure. This policy became effective January 27, 2005. Details of the clinical indications that are covered by Medicare and their respective data reporting requirements are available in the Medicare National Coverage Determination (NCD) Manual, which is on the Centers for Medicare & Medicaid Services (CMS) Web site at http://www.cms.hhs.gov/Manuals/IOM/itemdetail.asp?filterType=none&filterByDID=99&sortByDID=1&sortOrder=ascending&itemID=CMS014961. A provider can use either of two mechanisms to satisfy the data reporting requirement. Patients may be enrolled either in an Investigational Device Exemption trial studying ICDs as identified by the FDA or in the American College of Cardiology's National Cardiovascular Data Registry (ACC-NCDR) ICD registry. Therefore, in order for a beneficiary to receive a Medicare-covered ICD implantation for primary prevention, the beneficiary must receive the scan in a facility that participates in the ACC-NCDR ICD registry. We maintain a list of facilities that have been enrolled in this registry. Addendum IX includes the facilities that have been designated in the quarter covered by this notice. 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36906]] [GRAPHIC] [TIFF OMITTED] TN28JN10.114 [[Page 36907]] [GRAPHIC] [TIFF OMITTED] TN28JN10.115 [[Page 36908]] [GRAPHIC] [TIFF OMITTED] TN28JN10.116 [[Page 36909]] [GRAPHIC] [TIFF OMITTED] TN28JN10.117 [[Page 36910]] [GRAPHIC] [TIFF OMITTED] TN28JN10.118 [[Page 36911]] [GRAPHIC] [TIFF OMITTED] TN28JN10.119 [[Page 36912]] [GRAPHIC] [TIFF OMITTED] TN28JN10.120 [[Page 36913]] [GRAPHIC] [TIFF OMITTED] TN28JN10.121 [[Page 36914]] [GRAPHIC] [TIFF OMITTED] TN28JN10.122 [[Page 36915]] [GRAPHIC] [TIFF OMITTED] TN28JN10.123 [[Page 36916]] [GRAPHIC] [TIFF OMITTED] TN28JN10.124 [[Page 36917]] [GRAPHIC] [TIFF OMITTED] TN28JN10.125 [[Page 36918]] [GRAPHIC] [TIFF OMITTED] TN28JN10.126 [[Page 36919]] [GRAPHIC] [TIFF OMITTED] TN28JN10.127 [[Page 36920]] [GRAPHIC] [TIFF OMITTED] TN28JN10.128 [[Page 36921]] [GRAPHIC] [TIFF OMITTED] TN28JN10.129 [[Page 36922]] [GRAPHIC] [TIFF OMITTED] TN28JN10.130 [[Page 36923]] [GRAPHIC] [TIFF OMITTED] TN28JN10.131 [[Page 36924]] [GRAPHIC] [TIFF OMITTED] TN28JN10.132 [[Page 36925]] [GRAPHIC] [TIFF OMITTED] TN28JN10.133 [[Page 36926]] Addendum X Active CMS Coverage-Related Guidance Documents [January Through March 2010] On September 24, 2004, we published a notice in the Federal Register (69 FR 57325), in which we explained how we would develop coverage-related guidance documents. These guidance documents are required under section 731 of the MMA. In our notice, we committed to the public that, ``At regular intervals, we will update a list of all guidance documents in the Federal Register.'' Addendum X includes a list of active CMS guidance documents as of the ending date of the period covered by this notice. To obtain full- text copies of these documents, visit the CMS Coverage Web site at http://www.cms.hhs.gov/mcd/index_list.asp?list_type=mcd_1. Document Name: Factors CMS Considers in Commissioning External Technology Assessments. Date of Issuance: April 11, 2006. Document Name: Factors CMS Considers in Opening a National Coverage Determination. Date of Issuance: April 11, 2006. Document Name: (Draft) Factors CMS Considers in Referring Topics to the Medicare Coverage Advisory Committee. Date of Issuance: March 9, 2005. Document Name: National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage With Evidence Development. Date of Issuance: July 12, 2006. Addendum XI List of Special One-Time Notices Regarding National Coverage Provisions [January Through March 2010] As medical technologies, the contexts under which they are delivered, and the health needs of Medicare beneficiaries grow increasingly complex, our national coverage determination (NCD) process must adapt to accommodate these complexities. As part of this adaptation, our national coverage decisions often include multi-faceted coverage determinations, which may place conditions on the patient populations eligible for coverage of a particular item or service, the providers who deliver a particular service, or the methods in which data are collected to supplement the delivery of the item or service (such as participation in a clinical trial). We outline these conditions as we release new or revised NCDs. However, details surrounding these conditions may need to be shared with the public as ``one-time notices'' in the Federal Register. For example, we may require that a particular medical service may be delivered only in the context of a CMS-recognized clinical research study, which was not named in the NCD itself. We would then use Addendum XI of this notice, along with our coverage Web site at http://www.cms.hhs.gov/coverage, to provide the public with information about the clinical research study that it ultimately recognizes. Addendum XI includes any additional information we may need to share about the conditions under which an NCD was issued as of the ending date of the period covered by this notice. There were no Special One-Time Notices Regarding National Coverage Provisions published this quarter. Addendum XII--National Oncologic PET Registry (NOPR) In January 2005, we issued our decision memorandum on positron emission tomography (PET) scans, which stated that CMS would cover PET scans for particular oncologic indications, as long as they were performed in the context of a clinical study. We have since recognized the National Oncologic PET Registry as one of these clinical studies. Therefore, in order for a beneficiary to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the Registry. The following facilities have met the CMS's requirements for performing PET scans under National Coverage Determination CAG-00181N. 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37021]] [GRAPHIC] [TIFF OMITTED] TN28JN10.228 [[Page 37022]] [GRAPHIC] [TIFF OMITTED] TN28JN10.229 [[Page 37023]] [GRAPHIC] [TIFF OMITTED] TN28JN10.230 [[Page 37024]] [GRAPHIC] [TIFF OMITTED] TN28JN10.231 [[Page 37025]] [GRAPHIC] [TIFF OMITTED] TN28JN10.232 [[Page 37026]] [GRAPHIC] [TIFF OMITTED] TN28JN10.233 [[Page 37027]] [GRAPHIC] [TIFF OMITTED] TN28JN10.234 [[Page 37028]] [GRAPHIC] [TIFF OMITTED] TN28JN10.235 [[Page 37029]] [GRAPHIC] [TIFF OMITTED] TN28JN10.236 [[Page 37030]] [GRAPHIC] [TIFF OMITTED] TN28JN10.237 [[Page 37031]] [GRAPHIC] [TIFF OMITTED] TN28JN10.238 [[Page 37032]] [GRAPHIC] [TIFF OMITTED] TN28JN10.239 [[Page 37033]] [GRAPHIC] [TIFF OMITTED] TN28JN10.240 [[Page 37034]] [GRAPHIC] [TIFF OMITTED] TN28JN10.241 [[Page 37035]] [GRAPHIC] [TIFF OMITTED] TN28JN10.242 [[Page 37036]] [GRAPHIC] [TIFF OMITTED] TN28JN10.243 [[Page 37037]] [GRAPHIC] [TIFF OMITTED] TN28JN10.244 [[Page 37038]] [GRAPHIC] [TIFF OMITTED] TN28JN10.245 [[Page 37039]] [GRAPHIC] [TIFF OMITTED] TN28JN10.246 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[GRAPHIC] [TIFF OMITTED] TN28JN10.322 [[Page 37116]] [GRAPHIC] [TIFF OMITTED] TN28JN10.323 [[Page 37117]] [GRAPHIC] [TIFF OMITTED] TN28JN10.324 [[Page 37118]] [GRAPHIC] [TIFF OMITTED] TN28JN10.325 [[Page 37119]] [GRAPHIC] [TIFF OMITTED] TN28JN10.326 [[Page 37120]] [GRAPHIC] [TIFF OMITTED] TN28JN10.327 [[Page 37121]] [GRAPHIC] [TIFF OMITTED] TN28JN10.328 [[Page 37122]] [GRAPHIC] [TIFF OMITTED] TN28JN10.329 [[Page 37123]] [GRAPHIC] [TIFF OMITTED] TN28JN10.330 [[Page 37124]] [GRAPHIC] [TIFF OMITTED] TN28JN10.331 [[Page 37125]] [GRAPHIC] [TIFF OMITTED] TN28JN10.332 [[Page 37126]] [GRAPHIC] [TIFF OMITTED] TN28JN10.333 [[Page 37127]] Addendum XIII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities [January Through March 2010] On October 1, 2003, we issued our decision memorandum on ventricular assist devices for the clinical indication of destination therapy. We determined that ventricular assist devices used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for ventricular assist devices implanted as destination therapy. VAD Destination Therapy Facilities The following facilities have met the CMS facility standards for destination therapy VADs. ---------------------------------------------------------------------------------------------------------------- Facility Provider No. Date approved State Other information ---------------------------------------------------------------------------------------------------------------- Advocate Christ Medical Center, 4440 140208 12/17/2003 IL Joint Commission W 95th Street, Oak Lawn, Illinois. Certified on 05/26/ 2007. California Pacific Medical Center, 050047 03/19/2004 CA 2333 Buchanan Street, San Francisco, California. Baptist Memorial Hospital, 6019 440048 04/07/2004 TN Walnut Grove Road, Memphis, Tennessee. Duke University Medical Center, DUMC 340030 10/31/2003 NC Box 3943, Durham, North Carolina. Fairview-University Medical Center, 240080 10/28/2003 MN 2450 Riverside Avenue, Minneapolis, Minnesota. Allegheny General Hospital, 320 E 390050 12/10/2003 PA Joint Commission North Avenue, Pittsburgh, Certified on 03/28/ Pennsylvania. 2008. Barnes-Jewish Hospital, One Barnes- 260032 10/27/2003 MO Joint Commission Jewish Hospital Plaza, Saint Louis, Certified on 08/22/ Missouri. 2008. Brigham and Women's Hospital, 15 220110 01/09/2004 MA Francis Street, Boston, Massachusetts. Bryan LGH Medical Center East, 1600 S 280003 10/23/2003 NE 48 Street, Lincoln, Nebraska. Cedars-Sinai Medical Center, 8700 050625 12/29/2003 CA Beverly Boulevard, Los Angeles, California. Clarian Health Partners, Inc., 1701 150056 11/25/2003 IN N. Senate Avenue, Indianapolis, Indiana. Cleveland Clinic, 9500 Euclid Avenue, 360180 12/03/2003 OH Cleveland, Ohio. Hahnemann University Hospital, Broad 390290 12/22/2003 PA Joint Commission and Vine Streets, Philadelphia, Certified on 09/19/ Pennsylvania. 2008. Hospital of the University of 390111 10/28/2003 PA Joint Commission Pennsylvania, 3400 Spruce Street, Certified on 05/23/ Philadelphia, Pennsylvania. 2008. Henry Ford Hospital, 2799 W. Grand 230053 01/06/2004 MI Boulevard, Detroit, Michigan. Inova Fairfax Hospital, 3300 Gallows 490063 03/31/2004 VA Road, Falls Church, Virginia. Jewish Hospital, 200 Abraham Flexner 180040 11/10/2003 KY Way, Louisville, Kentucky. Jackson Memorial Hospital, 1611 NW 100022 01/12/2004 FL University of Miami. 12th Avenue, Miami, Florida. LDS Hospital, 8th Avenue and C 460010 10/23/2003 UT Street, Salt Lake City, Utah. Johns Hopkins Hospital, 600 N. Wolfe 210009/ 10/28/2003 MD Joint Commission Street, Baltimore, Maryland. 1790700904 Certified on 07/09/ 2008. Loyola University Medical Center, 140276 01/30/2004 IL 2160 S. 1st Avenue, Maywood, Illinois. Lutheran Hospital of Indiana, 7950 W. 150017 10/29/2003 IN Jefferson Boulevard, Fort Wayne, Indiana. Massachusetts General Hospital, 55 220071 12/15/2003 MA Fruit Street, Boston, Massachusetts. Mayo Clinic, 4500 San Pablo Road, 100151 11/06/2003 FL Jacksonville, Florida. Medical City Dallas Hospital, 7777 450647 12/03/2003 TX Forest Lane, Dallas, Texas. The Methodist Hospital, 6565 Fannin 450358 11/03/2003 TX Street, Houston, Texas. Montefiore Medical Center, 111 E. 330059 11/14/2003 NY 210th Street, Bronx, New York. Methodist Specialty and Transplant 450388 11/19/2003 TX Hospital, 8026 Floyd Curl Drive, San Antonio, Texas. Newark Beth Israel Medical Center, 310002 11/14/2003 NJ 201 Lyons Avenue, Newark, New Jersey. Mount Sinai Medical Center, 1190 5th 330024 11/25/2003 NY Avenue, New York, New York. New York-Presbyterian Hospital, 177 330101 10/28/2003 NY Columbia University Fort Washington Avenue, New York, Medical Center. New York. Ohio State University Medical Center, 360085 11/12/2003 OH 410 W. 10th Avenue, Columbus, Ohio. Oregon Health and Sciences 380009 11/21/2003 OR University, 3181 SW Sam Jackson Park Road, Portland, Oregon. OSF St Francis Medical Center, 530 NE 140067 11/12/2003 IL Glen Oak Avenue, Peoria, Illinois. Penn State Milton S Hershey Medical 390256 10/29/2003 PA Joint Commission Center, 500 University Drive, Certified on 05/19/ Hershey, Pennsylvania. 2008. Rush-Presbyterian-St Luke Medical 140119 11/14/2003 IL Center, 1653 W Congress Parkway, Chicago, Illinois. [[Page 37128]] Sentara Norfolk General Hospital, 600 490007 11/10/2003 VA Gresham Drive, Norfolk, Virginia. Sacred Heart Medical Center, 101 W 500054 01/12/2004 WA 8th Avenue, Spokane, Washington. Seton Medical Center, 1201 W. 38th 450056 01/13/2004 TX Street, Austin, Texas. Shands at the University of Florida, 100113 11/26/2003 FL 1600 SW Archer Road, Gainesville, Florida. Sharp Memorial Hospital, 7901 Frost 050100 12/01/2003 CA Joint Commission Street, San Diego, California. Certified on 07/18/ 2008. Stanford University Hospital and 050441 12/22/2003 CA Stanford University Clinics, 300 Pasteur Drive, Medical Center. Stanford, California. St Francis Hospital, 6161 S. Yale 370091 01/09/2004 OK Avenue, Tulsa, Oklahoma. St Luke's Medical Center, 2900 W 520138 11/03/2003 WI Oklahoma Avenue, Milwaukee, Wisconsin. St Luke's Episcopal Hospital, 6720 450193 10/28/2003 TX Bertner Avenue, Houston, Texas. St Vincent Hospital and Health 150084 01/05/2004 IN Services, 2001 W. 86th Street, Indianapolis, Indiana. St Paul Medical Center, 5909 Harry 450044 12/10/2003 TX Hines Boulevard, Dallas, Texas. Strong Memorial Hospital, 601 Elmwood 330285 10/29/2003 NY Joint Commission Avenue, Rochester, New York. Certified on 06/18/ 2008. Tampa General Hospital, 2 Columbia 100128 11/26/2003 FL Drive, Tampa, Florida. Temple University Hospital, 3401 N. 390027 11/03/2003 PA Broad Street, Philadelphia, Pennsylvania. Tufts-New England Medical Center, 750 220116 11/06/2003 MA Washington Street, Boston, Massachusetts. UCLA Medical Center, 10833 Le Conte 050262 12/10/2003 CA Avenue, Los Angeles, California. University Medical Center, 1501 N. 030064 10/29/2003 AZ Campbell Avenue, Tucson, Arizonia. University of Alabama at Birmingham 010033 10/29/2003 AL Health System, 500 22nd Street S, Birmingham, Alabama. University of Colorado Hospital, 4200 060024 11/06/2003 CO 9th & Colorado Campus, E. Ninth Avenue, Denver, Colorado. Joint Commission Certified on 07/23/ 2008. The University of Chicago Hospitals 140088 02/25/2004 IL and Health System, 5841 South Maryland Avenue, Chicago, Illinois. University of Iowa Hospitals and 160058 11/12/2003 IA Clinics, 200 Hawkins Drive, Iowa City, Iowa. University of Maryland Medical 210002 11/12/2003 MD Center, 22 S. Greene Street, Baltimore, Maryland. University of Michigan Health System, 230046 10/27/2003 MI Joint Commission 1500 E. Medical Center Drive, Ann Certified on 03/28/ Arbor, Michigan. 2008. University of North Carolina 340061 05/05/2004 NC Hospitals, 101 Manning Drive, Chapel Hill, North Carolina. University of Utah Hospital, 50 N 460009 12/22/2003 UT Medical Drive, Salt Lake City, Utah. University of Virginia Health System, 490009 01/12/2004 VA 1215 Lee Street, Charlottesville, Virginia. University of Washington Medical 500008 01/15/2004 WA Center, 1959 NE Pacific Street, Seattle, Washington. University of Wisconsin Hospitals and 520098 12/03/2003 WI Clinics, 600 Highland Avenue, Madison, Wisconsin. USC University Hospital, 1500 San 050696 01/09/2004 CA Pablo, Los Angeles, California. UPMC Presbyterian, 200 Lothrop 390164 10/23/2003 PA Joint Commission Street, Pittsburgh, Pennsylvania. Certified on 06/11/ 2008. Virginia Commonwealth University 490032 04/08/2004 VA Medical College of Medical Center, 401 North 12th Virginia Hospitals. Street, Richmond, Virginia. Vanderbilt University Medical Center, 440039 10/28/2003 TN 1161 21st Avenue S, Nashville, Tennessee. Ochsner Clinic Foundation, 1514 190036 06/29/2004 LA Jefferson Highway, New Orleans, Louisiana. Baylor University Medical Center, N/A 10/04/2007 TX Joint Commission 3500 Gaston Avenue, Dallas, TX. Certified on 10/04/ 2007. The University of Michigan Hospitals 230046 03/28/2008 MI Joint Commission and Health Centers, 1500 East Certified on 03/28/ Medical Center Drive, Ann Arbor, MI. 2008. Saint Mary's Hospital, 1216 Southwest N/A 02/27/2008 MN Joint Commission Second Street, Rochester, MN. Certified on 02/27/ 2008. Allegheny General Hospital, 320 East N/A 03/08/2008 PA North Avenue, Pittsburgh, PA. Washington Hospital Center, 110 09-0011 04/23/2008 DC Joint Commission Irving Street, NW, Washington, DC. Certified on 04/23/ 2008. [[Page 37129]] Integris Baptist Medical Center, 3300 1831103654 08/13/2008 OK Joint Commission Northwest Expressway, Oklahoma City, Certified on 08/13/08. OK. Mayo Clinic Hospital, 5777 East Mayo 030103 02/27/2009 AZ Joint Commission Boulevard, Phoenix, AZ. Certified on 02/27/09. Northwestern Memorial Hospital, 251 140281 03/17/2009 IL Joint Commission E. Huron Street, Chicago, IL. Certified on 03/17/09. Lancaster General Hospital, 555 North 390100 05/20/2009 PA Joint Commission Duke Street, Lancaster, PA. certified on 05/20/09. Hartford Hospital, 80 Seymour Street, 070025 05/29/2009 CT Joint Commission Hartford, CT. certified on 05/29/09. Morristown Memorial Hospital, 100 310015 06/17/09 NJ Joint Commission Madison Avenue, Morristown, NJ. certified on 6/17/09. Thomas Jefferson University Hospital, 390174 08/05/09 PA Joint Commission 111 South 11th Street, Philadelphia, certified on 8/5/09. PA. Emory University Hospital, 1364 110010 08/19/09 GA Joint Commission Clifton Road, Atlanta, GA. certified on 8/19/09. Maine Medical Center, 22 Bramhall 200009 02/03/09 ME Joint Commission Street, Portland, ME. certified on 02/03/09. University of Kentucky Health Care-- .............. 02/11/09 KY Chandler Hospital, 800 Rose Street, Lexington, KY. Sutter Memorial Hospital, 5151 F 050108 10/21/09 CA Joint Commission Street, Sacramento, California. Certified on 10/21/09. Baptist Health Medical Center--Little 040114 12/02/09 AR Joint Commission Rock, 9601 Interstate 630, Exit 7, Certified on 12/02/09. Little Rock, Arizona. Westchester Medical Center, 100 Woods 330234 01/05/10 NY Joint Commission Road, Valhalla, New York. Certified on 01/05/10. ---------------------------------------------------------------------------------------------------------------- Addendum XIV Lung Volume Reduction Surgery (LVRS) [January Through March 2010] Three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS): National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs), Credentialed by the Joint Commission (formerly, the Joint Commision on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for LVRS, and Medicare approved for lung transplants. Only the first two types are in the list. ---------------------------------------------------------------------------------------------------------------- Facility name Date approved State Type of certification ---------------------------------------------------------------------------------------------------------------- Baylor College of Medicine, Houston, N/A TEXAS..................... NETT Texas. Brigham and Women's Hospital, Boston, N/A MASSACHUSETTS............. NETT MA. Cedars-Sinai Medical Center, Los N/A CALIFORNIA................ NETT Angeles, CA. Chapman Medical Center, Orange, CA..... N/A CALIFORNIA................ NETT Cleveland Clinic Foundation, Cleveland, N/A OHIO...................... NETT OH. Columbia University, New York, NY...... N/A NEW YORK.................. NETT Duke University Medical Center, Durham, N/A NORTH CAROLINA............ NETT NC. Johns Hopkins Hospital, Baltimore, MD.. N/A MARYLAND.................. NETT Kaiser Foundation Hospital--Riverside, 09/20/2006 CALIFORNIA................ Joint Commission Riverside, CA. Long Island Jewish Medical Center, New N/A NEW YORK.................. NETT Hyde Park, NY. Mayo Clinic, Rochester, MN............. N/A MINNESOTA................. NETT Memorial Medical Center, Springfield, 12/13/2006 ILLINOIS.................. Joint Commission IL. National Jewish Medical Center, Denver, N/A COLORADO.................. NETT CO. The Ohio State University Hospital, N/A OHIO...................... Joint Commission Columbus, OH. Ohio State University Medical Center, N/A OHIO...................... NETT Columbus, OH. Saint Louis University, Saint Louis, MO N/A MISSOURI.................. NETT Temple University Hospital, 08/23/2008 PENNSYLVANIA.............. Joint Commission Philadelphia, PA. UCLA Medical Center, Los Angeles, CA... N/A CALIFORNIA................ NETT University of California, San Diego, N/A CALIFORNIA................ NETT San Diego, CA. University of Maryland Medical Center, N/A MARYLAND.................. NETT Baltimore, MD. University of Michigan Medical Center, N/A MICHIGAN.................. Joint Commission Ann Arbor, MI. University of Pennsylvania, N/A PENNSYLVANIA.............. NETT Philadelphia, PA. University of Pittsburgh, Pittsburgh, N/A PENNSYLVANIA.............. NETT PA. University of Washington, Seattle, WA.. N/A WASHINGTON................ NETT Washington University/Barnes Hospital, N/A MISSOURI.................. Joint Commission Saint Louis, MO. Allegheny General Hospital, Pittsburgh, 04/23/2008 PENNSYLVANIA.............. Joint Commission PA. ---------------------------------------------------------------------------------------------------------------- Addendum XV--Medicare-Approved Bariatric Surgery Facilities On February 21, 2006, we issued our decision memorandum on bariatric surgery procedures. We determined that bariatric surgical procedures are reasonable and necessary for Medicare beneficiaries who have a body-mass index (BMI) greater than or equal to 35, have at least one co-morbidity related to obesity, and have been previously [[Page 37130]] unsuccessful with medical treatment for obesity. This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) Certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006). The following facilities have met our minimum facility standards for bariatric surgery and have been certified by American College of Surgeons (ACS) or American Society for Metabolic and Bariatric Surgery (ASMBS). 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HW13029................ 06/07/2006 CA........... Early and Long- Dr. Daniel Silverman. 10833 Le Conte Avenue.......... Term Value of Los Angeles, CA 90095.......... Imaging Brain Metabolism. Santa Monica-UCLA Medical W11817A................ 01/12/2007 CA........... N/A............... N/A. Center. 1245 16th Street............... Suite 105...................... Santa Monica, CA 90404......... University of Buffalo.......... 14414A................. 03/12/2007 NY........... Metabolic Cerebral Dr. Daniel Silverman. 3435 Main Street............... Imaging in Buffalo, NY 14214.............. Incipient Dementia (MCI-ID). Center for Alzheimer's Care, 460009................. 02/17/2009 UT........... Metabolic Cerebral Norman Foster, M.D. Imaging and Research Imaging in (University of Utah). Incipient 650 Komas Drive................ Dementia (MCI-ID). Suite 106-A.................... Salt Lake City, UT 84108....... Medical University of South 1073605879............. 02/17/2009 SC........... N/A............... Kenneth Spicer. Carolina. 169 Ashley Avenue.............. PO Box 250322.................. Charleston, SC 29425........... Cedars-Sinai Medical Center.... 951644600.............. 10/09/2009 CA........... ``Early and Long- Dr. Alan Waxman. 8700 Beverly Boulevard......... term Value of Nuc Suite 1239................. Imaging Brain Los Angeles, CA 90048.......... Metabolism''. -------------------------------------------------------------------------------------------------------------------------------------------------------- [FR Doc. 2010-15257 Filed 6-25-10; 8:45 am] BILLING CODE 4120-01-P